An observational study in Respiratory Viral Infection and SARS CoV 2 Infection, sponsored by Medical Research Council Unit, The Gambia. Active, not recruiting at 1 site in Gambia. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Medical Research Council Unit, The Gambia · Observational
Primary endpoints
A prospective, observational cohort study within households in West Coast Region and Kanifing Municipality, The Gambia. A total of 50 - 70 households will be recruited. All members of the household will be included other than those who do not meet the eligibility criteria or decline to consent for the study. Participants will be enrolled for a total of 52 weeks, undergoing weekly field visits, along with an enrolment visit (V1), 6-month visit (V2) and 12-month visit (V3), which will all be clinic based. Clinic visits will collect anthropometric, socio-demographic and clinical data (including risk for acquisition of SARS-CoV- 2). In addition, a combined throat and nose swab (TNS), nasal lining fluid (NLF) using a synthetic absorptive matrix (SAM) strip, and a blood sample will be taken. Weekly visits will be done at the participants' homes or work place. During these visits, TNS will be collected, along with the presence of symptoms consistent with respiratory viral infections. In addition, participants who have symptoms consistent with influenza-like-illnesses (ILI) will have unscheduled visits where clinical data and a TNS is collected, which will be tested in real time for SARS-CoV-2 using PCR. Participants will be informed of their results within 24 hours after this TNS sample is collected at unscheduled ILI visits. Positive results will be communicated to the Ministry of Health for their records and contact tracing. Weekly TNS from all household members of any positive SARS-CoV-2 case will also be tested in real time for SARS-CoV-2 for 4 weeks following the most recent SARS-CoV- 2 positive case in the household. All participants with symptomatic SARS-CoV-2 detected at an unscheduled ILI visit will be seen at an additional clinic visit (post-covid follow up), where further TNS, NLF and blood samples will be taken.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 349 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Medical Research Council Unit, The Gambia is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Households will be excluded from participation if they meet any of the following criteria:
Participants will be excluded from participation if they meet any of the following criteria:
Participants must:
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Incidence of symptomatic and asymptomatic infection with SARS-CoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testing
with SARS-Incidence of symptomatic and asymptomatic infection with SARS-CoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testingCoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testing * Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2 * Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2
Time frame: 12 months
Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2
Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2
Time frame: 12 months
Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2
Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2
Time frame: 12 months
Secondary attack rate and household cumulative infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses
Secondary attack rate and household cumulative infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses * Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid * Presence of risk factors for symptomatic and asymptomatic infection with respiratory viruses * Antibody and T cell kinetics of SARS-CoV-2 following infection * Associations between the magnitude and quality of antibody and T cell responses to seasonal coronaviruses and protection from infection with SARS-CoV-2 * Associations between infection with non-SARS-CoV-2 respiratory viruses and protection from infection with SARS-CoV-2 * Associations between upregulation of gene expression in the mucosa, including interferon stimulated genes (ISGs), and protection from infection with SARS-CoV-2
Time frame: 12 months
Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid
Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid
Time frame: 12 months
Presence of risk factors for symptomatic and asymptomatic infection with respiratory viruses
Presence of risk factors for symptomatic and asymptomatic infection with respiratory viruses
Time frame: 12 months
Antibody and T cell kinetics of SARS-CoV-2 following infection
Antibody and T cell kinetics of SARS-CoV-2 following infection
Time frame: 12 months
Associations between the magnitude and quality of antibody and T cell responses to seasonal coronaviruses and protection from infection with SARS-CoV-2
Associations between the magnitude and quality of antibody and T cell responses to seasonal coronaviruses and protection from infection with SARS-CoV-2
Time frame: 12 months
Associations between infection with non-SARS-CoV-2 respiratory viruses and protection from infection with SARS-CoV-2
Associations between infection with non-SARS-CoV-2 respiratory viruses and protection from infection with SARS-CoV-2
Time frame: 12 months
Associations between upregulation of gene expression in the mucosa, including interferon stimulated genes (ISGs), and protection from infection with SARS-CoV-2
Associations between upregulation of gene expression in the mucosa, including interferon stimulated genes (ISGs), and protection from infection with SARS-CoV-2
Time frame: 12 months
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Medical Research Council Unit, The Gambia